JPM25: Regeneron CEO says it needs more 'arrows in its quiver' as Eylea HD sales fall short

After Regeneron Chief Scientific Officer George Yancopoulos, M.D., Ph.D., spent more than 25 minutes waxing about the company’s deep pipeline Monday at the J.P. Morgan Healthcare Conference, CEO Len Schleifer, M.D., Ph.D., was asked about disappointing sales of high-dose Eylea.

“I’d be happier to talk about the pipeline,” Schleifer said.

Earlier on Monday, Regeneron shared preliminary results from the fourth quarter that showed Eylea HD generated just $305 million in the U.S. It was a stunning drop-off from the $392 million the eye disease product generated in the U.S. in the third quarter and fell woefully short of the analyst expectation of $411 million, prompting Evercore ISI analyst Cory Kasimov to call the result “relatively dismal.”

Since it was approved in August 2023, sales of Eylea HD had trended positively, increasing from $200 million to $304 million in the first two quarters of 2024.

“Eylea HD is a big advance in our minds over Eylea,” Schleifer said. “But I think it needs a few more arrows in its quiver.”

Schleifer raced through a checklist of items Regeneron hopes to achieve for Eylea HD including gaining approval for it to be administered in a prefilled syringe by the middle of 2025.

The company has an FDA target date of April 20 for a decision on Eylea HD’s dosing interval to be stretched to 24 weeks for patients with macular degeneration.

Regeneron also hopes for a retinal vein occlusion (RVO) nod and for an every four-week dosing option to maximize dosing flexibility for Eylea HD.

While those potential advancements may help Eylea HD regain its traction, there was no explanation from the company about its sudden sales decline.

“We accomplished some switching to Eylea HD, perhaps not as much as we would have liked,” Schleifer said. “Our marketing team, I think is really expert. We know the retinal community very well. But we didn’t have all the tools necessary to optimize Eylea HD.”

The result raises serious doubts about the ability of Regeneron to regain its hemorrhaging market share as Roche’s Vabysmo continues to surge.

For all of 2024, the Eylea franchise accounted for $6 billion in U.S. sales, which was a 1% increase from 2023. Meanwhile, in the first three quarters of 2024, Roche's rival drug Vabysmo racked up sales of $3.2 billion worldwide.

Roche has been a step ahead of Regeneron throughout its advancement of Vabysmo, which was originally approved in January 2022 to treat diabetic wet-age macular degeneration and macular edema and then added nods for RVO in October 2023 and for its prefilled syringe in July of last year.